Concepta Diagnostics Turning Concepts into Conception and engaging a - - PowerPoint PPT Presentation

Turning Concepts into Conception and engaging a highly motivated customer base

Concepta Diagnostics

Strictly Private and Confidential. Not to be copied.

Penny McCormick Annual General Meeting 2nd July 2020

Document information

The information contained in this document and made verbally to you (together the “Presentation”) is confidential and is being supplied to persons with professional experience in matters relating to investments and/or to high net worth companies as described in Article 19(5) and 49(2) respectively of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2001 (SI. 2001/No.1335) (as amended) made pursuant to section 21(5) of the Financial Services and Markets Act 2000 and, if permitted by applicable law, is being supplied outside the United Kingdom to professionals or institutions whose ordinary business involves them in investment activities. The information contained in this document is not intended to be viewed by, or distributed or passed on (directly or indirectly) to, any other class of persons. Accordingly, information contained in the Presentation is being supplied to you solely for your information and may not be copied, reproduced or further distributed to any person or published in whole or in part, for any purpose. In particular, the distribution of this document in jurisdictions other than the United Kingdom may be restricted by law and persons into whose possession this document comes should inform themselves about, and

• bserve, any such restrictions. Any failure to comply with these restrictions may constitute a violation of laws of any such other jurisdiction.

No representation or warranty, express or implied, is given as to the accuracy of the information or opinions contained in the Presentation and no liability is accepted for any such information or opinions by Concepta Plc (the “Company”) or any of its directors, members, officers, employees, agents or advisers. Notwithstanding this, nothing in this paragraph shall exclude liability for any representation or warranty made fraudulently. The Presentation does not constitute any part of an offer of, or invitation to apply for, securities in the Company.

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Agenda

Concepta Leadership Non-Exec Board Vision, Mission, Purpose 2020 Commitments Technology Our place in the market Market opportunity Commercial Strategy R&D Operational leverage 2020 Delivery & Milestones Forward Principles Future investment Summary

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New leadership team for growth

Penny McCormick CEO

Highly experienced consumer MedTech team with leadership in women’s device development and commercialisation

Maddy Kennedy CFO Dr Karen Whiting CTO Lisa Link Product Specialist

• Women’s health

commercial specialist

• 15 years in women’s

health medical devices plus IVD

• FMCG marketing

leadership

• Operational &

regulatory ownership to ISO 13485, IVDD

• In/Out licensing: £32m

Bayer deal

• Proven CFO for

transformational out- licensing, acquisition and IPO

• 20 years life science and

tech specialties

• Digital health &

therapeutics portfolio, Alliance Pharma

• 20 years immunoassay

expertise BTB and OTC

• Fertility specialisms:

Unipath, male fertility assay development

• Multiple product launches
• Programme leadership &

delivery

• Medicine Management

software development

• 30 years consumer health

and beauty

• 12 years Unipath VP OTC;

Clearblue, Persona

• Launch of first ever digital

pregnancy test

• Annualised category

spend to €10m

Strictly Private and Confidential. Not to be copied.

Non-Exec Board

Adam Reynolds Chairman

Experts in commercialisation and investment of IVDs and consumer technology

Peter Dines Non-Exec Director Neil Mesher Non-Exec Director Lyn Rees Non-Exec Director

Chairman, investor and NED portfolio including EKF, Yourgene COO and Head of Lifesciences Mercia Asset Management Plc. Former MD positions in medical device tech space CEO of YourGene Health. Former CEO and Directorships including Alere, The BBI Group CEO Phillips UK & Eire. Board member of the Association of British Healthcare Industries (ABPI)

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Our Vision

Is a world where all women and couples have access to information about their reproductive health, without being misled.

Our vision

for Concepta, Technology and Women

Our Mission

Is to help women and couples to start their journey at home and make fact-based decisions as early as possible, supporting their decision making on next steps, where their body and financial circumstances afford them the ability to do so. Is for myLotus to be the go-to brand for trusted conception and fertility advice and tracking, and up to date content regarding fertility.

Our Purpose

Is to use our expertise and technology to improve self care and support individuals and organisations with a need for personalized diagnostics or monitoring. Is to analyse data to demonstrate our own effectiveness and learn more about women’s cycles so that we can educate more effectively. Is to be a highly ethical, trusted organisation that values its workforce and rewards talent; that provides a safe and supporting working environment, whilst empowering its team to deliver for the good of its customer base.

Strictly Private and Confidential. Not to be copied.

The only fertility monitor that captures success rates with its own pregnancy testing regime: visible evidence Sophisticated OD analysis, converted to analyte concentration with 99% accuracy Quantitative LH testing throughout the cycle, with a pregnancy test at the end of the cycle 10 minutes to read a test, with monitor prompting tests: ease of use Option to test more than once a day – capturing LH surges regardless of whether they last hours or days

Finding reliable ways to determine the moment of ovulation is a critical task in the control of human conception

Our superior technology

that proves itself

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myLotus

Digital

• vulation tests

(Clearblue) Fertility monitor + tests (Clearblue) Temperature methods (Ava) Fertile window Yes Yes but with limitations Yes but with limitations No Predictive Yes Retrospective Retrospective Retrospective Hormone profile Yes No No No App for easy UI Yes Some Yes Some Controlled sample Yes No No N/A Full cycle data Yes No Limited (low, high, peak) Yes Compare cycles Yes (12) Limited Yes (6) Yes Irregular cycles Yes No No Yes PCOS Yes No No No LH surge, no ovulation Yes No No No Unique to you Yes No No No Month 1 cost £149.00 £37.00 £106.70 £349.00 Month 2+ cost £59.00 £37.00 £26.70 N/A

Works for ALL women Real time testing Laboratory equivalence Each monthly cycle, presented via the myLotus App, provides a clear cycle map Ovulation can be understood, and predicted

Commercially available OPKs have testing thresholds ranging from 20 to 50 mIU/ml. That’s a significant variation. So if

• ne experiences a low LH

surge one month, and the test isn’t very sensitive, results may show a woman that she didn’t ovulate — when she actually did.

Making a difference

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1 MarketWatch. 2. NICE. 3. Alliende et al., Mean versus individual hormonal profiles in the menstrual cycle; Fertility and Sterility 2002

Market opportunity in growth sector

OPK = Ovulation predictor kits Strictly Private and Confidential. Not to be copied.

• 4. Statista 2020. 5. Grand View Research

Market opportunity in growth sector

Social acceptance for assisted conception support and advice: social media driven Declining fertility rates

• verall

Increasing engagement with apps and tracking devices: greater engagement with our own health and lifestyle Delayed conception: Fertility rate of women 40+ surpassed that of women under 20 for the first time in 2016 (ONS). Average age

• f mothers at childbirth is

30.6 years4 Highly accurate technology coming to market Improved success rates of IVF (2018 value: $17.7bn5). 70% of clinics privately funded Declining male fertility: c.50%

Key Growth Drivers

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SPAIN ITALY FRANCE UK GERMANY TOTAL Population 46m 60m 65m 68m 84m OPK retail units 228k 296k 322k 336k 413k Clinic IUI Cycles 9.2k 11.9k 13k 13.5k 16.6k 5% of retail units share 11.4k 14.8k 16.1k 16.8k 20.65k 79.8k Revenue £4.1m £5.4m £5.9m £6.1m £7.5m £29m 5% of IUI share 0.5k 0.6k 0.7k 0.7k 0.8k 3.3k Revenue £182k £219k £256k £256k £292k £1.2m 5% Revenue Potential £4.3m £5.6m £6.2m £6.4m £7.8m £30.3m

We have the potential to increase the addressable market value due to premium pricing, and drive value into the category

Based on actual UK retail data (IRI, April 2019):

• Estimate 1% of OPK volume in Europe

£6m

• 5% of European OPK test volume is

estimated c. £30m

• Our aim is to secure this range

percentage over 3yr period

Attractive growth potential

OPK = Ovulation predictor kits IUI = Intrauterine Insemination Strictly Private and Confidential. Not to be copied.

• Evolve the look and

feel of myLotus

• Redefine the brand
• Make it memorable

and meaningful

• Not a ‘me too’.
• Carve our own clear

space

• Fact-based
• Assertive in our

position as superior to

• ther offerings
• Use assets to

strengthen message

• Customers

expectations are established around data and clarity

• Standout
• Show advantages

against the competition

• Explore strengthening
• f claims
• Clinical trial
• Clinical endorsement-

NHS as primary choice

• Network of advocates
• Word of mouth within

a highly engaged network

• Gold standard,

informative website as primary asset

• Quality news
• Full launch programme
• Clinicians as advocates

A key driver of our commercial success is to own the digital fertility space, which is currently relatively unoccupied

PRODUCT POSITION CLAIMS AND MESSAGING ENDORSEMENT/EN GAGEMENT AWARENESS

Compete Influence

Commercial strategy pillars

Transitioning from Femtech to an ambitious challenger brand

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The most comprehensive test package on the market:

• unrivalled. LH, PdG, HcG

Best in class technology Bluetooth enabled Combined IOS and Android App providing real-time data Positioned as more valuable proposition than current OPKs

Building on effective technology in a category of R&D inertia

R&D investment

New V2 monitor in Q1 2021

Building data profile to demonstrate efficacy within 3 months of trying Beyond V2 Innovation, male fertility In and out licensing

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Operational leverage

High level cost control Develop pipeline for in-licensing: driven by clinical and technical advisory board Scalable model Costs channeled into focused commercialization Agile and flexible working

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In 2020 we commit to delivering

1. Revenue growth through effective cross-channel activity 2. 33% reduction in operational overheads 3. Reshaped Concepta team, plus appointment of highly skilled marketing team 4. Regulatory approval of new V2 technology 5. V3 technology pipeline progression 6. Design and launch a new App 7. Definition of milestone-based growth plan 8. Solid foundations for future growth

Concepta Concepts Conception

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Key milestones

Q2 Q3 Q4 Q4

2020 2021

Q1

New Marketing team UK ecommerce strategy launch New App launch Certification

• f V2

Switch to

• utsource

manufacturing model European ecommerce rollout Commercial launch of V2 Completion of clinical study: myLotus against ultrasound V3 Feasibility commence

Q2 Q3 Q3 Q2

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Technology Team Operation Delivery

Best in class fertility monitoring Led by women with female health expertise Robust, futureproofed Clear growth plan Exploration of male fertility, in pregnancy technology Lateral flow expertise Agile, lowest overheads for maximum commercialization Horizontal and vertical market expansion: derisk In licensing, JV Commercially-led Flexible working solutions to attract top talent Milestone based delivery: timing is critical Opportunities for current platform: out licensing Well networked, wide reach Maximise ecommerce model for optimized margins Demonstration of YOY growth

Clear principles for growth

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Financial high-lights

• EBITDA loss £2.2m
• Cash at year end £0.62m
• £2.2m (net of issue expenses) share placing secured in April 2019

Post balance sheet events

• £1.7m (net of issue expenses) share placing secured in April 2020
• Leases and assets for Doncaster manufacturing site assigned to third

party in April 2020 for a total cash consideration of approximately £0.3m

• Contract manufacturing agreement signed April 2020 expected to

generate annualised overhead costs savings of at least £0.23m Initial ask R&D App development

£ 75.5k

V2 development

£ 375.7k

Regulatory

£ 109.1k

Technology transfer

£ 136.9k

Marketing

£ 977.8k

Strengthening the foundations

£ 514.4k

£ 2,189.5k

Use of the funds raised Apr-20

2019 Results

6% 31% 41% 22%

Expenses

Marketing Research & development Strengthening the foundations Technology transfer £- £1.5m £3.0m Q1 Q2 Q3 Q4

Strengthening the foundations Investing in growth

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Concepta combines innovative new launches with fact-based info resources to meet the needs of women and couples An agile, solutions-focused healthcare business, and with the potential to diversify into new markets and exploit our proprietary technology Overhead reduction from 2020 to improve our operational leverage and share regulatory load Efficient and effective, and focused on a commercialization footprint that is applied to each territory Top talent with flexible working and benefits aligned to company growth Strong foundations for growth with scalability

Changing the way all women can plan their Conception

Concepta in summary

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